FDA NDC Directory · JSON-LD · Markdown

FLUZONE HIGH DOSE NORTHERN HEMISPHERE

NDC 49281-126 · VACCINE · INJECTION, SUSPENSION

Generic nameINFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (A/MISSOURI/11/2025 PDM09-LIKE VIRUS) (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/MICHIGAN/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)
Labeler / ManufacturerSanofi Vaccines US Inc.
Marketing categoryBiologic License Application · App BLA103914
Dosage form / routeINJECTION, SUSPENSION · INTRAMUSCULAR
Active ingredientsINFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) (60 ug/.5mL)
INFLUENZA A VIRUS A/MICHIGAN/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (60 ug/.5mL)
INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED) (60 ug/.5mL)
Marketing started20260702
Marketing ended20270630
Package count1

External sources

Source: openFDA. Public-domain (CC0).